[Federal Register Volume 90, Number 128 (Tuesday, July 8, 2025)]
[Notices]
[Pages 30098-30099]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-12610]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Mark Agresti, M.D.; Decision and Order
On November 29, 2023, the Drug Enforcement Administration (DEA or
Government) issued an Order to Show Cause (OSC) to Mark Agresti, M.D.,
of Palm Beach, Florida (Registrant). Request for Final Agency Action
(RFAA), Exhibit (RFAAX) 2, at 1, 3. The OSC proposed the revocation of
Registrant's DEA Certificate of Registration No. BA2032441, alleging
that Registrant has ``been mandatorily excluded from Federal health
care programs pursuant to 42 U.S.C. 1320a-7(a).'' Id. at 1 (citing 21
U.S.C. 824(a)(5)).
The OSC notified Registrant of his right to file a written request
for hearing, and that if he failed to file such a request, he would be
deemed to have waived his right to a hearing and be in default. Id. at
2 (citing 21 CFR 1301.43). Here, Registrant did not request a hearing.
RFAA, at 2.\1\ ``A default, unless excused, shall be deemed to
constitute a waiver of the registrant's/applicant's right to a hearing
and an admission of the factual allegations of the [OSC].'' 21 CFR
1301.43(e).
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\1\ Based on the Government's submissions in its RFAA dated
November 26, 2024, the Agency finds that service of the OSC on
Registrant was adequate. The included Declaration from a DEA
Diversion Investigator (DI) indicates that on December 1, 2023, the
DI traveled to Registrant's attorney's office and personally served
Registrant's attorney with a copy of the OSC. RFAAX 3, Attachment D.
Registrant's attorney signed a Form DEA-12, confirming receipt of
the OSC. Id.
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Further, ``[i]n the event that a registrant . . . is deemed to be
in default . . . DEA may then file a request for final agency action
with the Administrator, along with a record to support its request. In
such
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circumstances, the Administrator may enter a default final order
pursuant to [21 CFR] Sec. 1316.67.'' Id. at 1301.43(f)(1). Here, the
Government has requested final agency action based on Registrant's
default pursuant to 21 CFR 1301.43(c), (e), (f), 1301.46. RFAA, at 4;
see also 21 CFR 1316.67.
Findings of Fact
The Agency finds that, in light of Registrant's default, the
factual allegations in the OSC are deemed admitted. 21 CFR 1301.43(e).
Accordingly, Registrant admits that in 2022, he was convicted of one
count of conspiracy to commit health care fraud and wire fraud, and 11
counts of health care fraud, in violation of 18 U.S.C. 1349, 1347.
RFAAX 2, at 2. As a result of Registrant's conviction,\2\ the United
States Department of Health and Human Services, Office of Inspector
General (HHS/OIG), mandatorily excluded Registrant from participation
in Medicare, Medicaid, and all federal health care programs pursuant to
42 U.S.C. 1320a-7(a) for a minimum period of 47 years. Id. The
exclusion became effective on January 19, 2023. Id. Accordingly, the
Agency finds substantial record evidence that Registrant has been
excluded from participation in Medicare, Medicaid, and all Federal
health care programs.
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\2\ The underlying conviction forming the basis for mandatory
exclusion from participation in federal health care programs need
not involve controlled substances to provide the grounds for
revocation or denial pursuant to Section 824(a)(5). See Moustafa M.
Aboshady, M.D., 90 FR 15992, 15993 n.5 (2025) (collecting cases).
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Discussion
Pursuant to 21 U.S.C. 824(a)(5), the Attorney General may suspend
or revoke a registration upon finding that the registrant ``has been
excluded (or directed to be excluded) from participation in a program
pursuant to section 1320a-7(a) of Title 42.''
The OSC solely alleges that Registrant's registration should be
revoked as a result of his mandatory exclusion ``from participation in
Medicare, Medicaid, and all Federal health care programs pursuant to 42
U.S.C. 1320a-7(a).'' RFAAX 2, at 1 (citing 21 U.S.C. 824(a)(5)). Above,
the Agency found that HHS/OIG mandatorily excluded Registrant from
participation in Medicare, Medicaid, and all Federal health care
programs pursuant to 42 U.S.C. 1320a-7(a), for a minimum of 47 years.
Id. at 2. Accordingly, the Agency finds that the Government established
a prima facie case for revoking Registrant's registration, that
Registrant did not rebut that prima facie case, and that there is
substantial record evidence supporting the revocation of Registrant's
registration. 21 U.S.C. 824(a)(5).
Sanction
Where, as here, the Government has presented a prima facie case
showing that Registrant's registration should be revoked, the burden
shifts to Registrant to show why he can be entrusted with the
responsibility carried by a registration. Morall v. Drug Enforcement
Admin., 412 F.3d 165, 174 (D.C. Cir. 2005); Jones Total Health Care
Pharmacy, 881 F.3d 823, 830 (11th Cir. 2018); Garrett Howard Smith,
M.D., 83 FR 18882 (2018). The issue of trust is necessarily a fact-
dependent determination based on the circumstances presented by the
individual registrant. Jeffrey Stein, M.D., 84 FR 46968, 46972 (2019);
see also Jones Total Health Care Pharmacy, 881 F.3d at 833. Moreover,
as past performance is the best predictor of future performance, the
Agency has required that registrants who have committed acts
inconsistent with the public interest must accept responsibility for
those acts and demonstrate that they will not engage in future
misconduct. Jones Total Health Care Pharmacy, 881 F.3d at 833. A
registrant's acceptance of responsibility must be unequivocal. Id. at
830-31. In addition, a registrant's candor during the investigation and
hearing has been an important factor in determining acceptance of
responsibility and the appropriate sanction. Id. Further, the Agency
has found that the egregiousness and extent of the misconduct are
significant factors in determining the appropriate sanction. Id. at 834
and n.4. The Agency has also considered the need to deter similar acts
by the specific registrant and by the community of registrants. Jeffrey
Stein, M.D., 84 FR at 46972-73.
Here, Registrant failed to answer the allegations contained in the
OSC, submit a corrective action plan, or otherwise avail himself of the
opportunity to refute the Government's case. As such, Registrant has
made no representations as to his future compliance with the CSA nor
demonstrated that he can be entrusted with registration. Moreover, the
evidence presented by the Government shows that Registrant was
convicted of charges related to health care fraud, further indicating
that Registrant cannot be entrusted with registration.
Accordingly, the Agency will order the revocation of Registrant's
registration.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No.
BA2032441, issued to Mark Agresti, M.D. Further, pursuant to 28 CFR
0.100(b) and the authority vested in me by 21 U.S.C. 823(g)(1), I
hereby deny any pending applications of Mark Agresti, M.D., to renew or
modify this registration, as well as any other pending application of
Mark Agresti, M.D., for additional registration in Florida. This Order
is effective August 6, 2025.
Signing Authority
This document of the Drug Enforcement Administration was signed on
July 1, 2025, by Acting Administrator Robert J. Murphy. That document
with the original signature and date is maintained by DEA. For
administrative purposes only, and in compliance with requirements of
the Office of the Federal Register, the undersigned DEA Federal
Register Liaison Officer has been authorized to sign and submit the
document in electronic format for publication, as an official document
of DEA. This administrative process in no way alters the legal effect
of this document upon publication in the Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2025-12610 Filed 7-7-25; 8:45 am]
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